The Safety of Biosimilars and the importance of the INN to track and trace the use of a medicine gi

Tracking and tracing the use of all biologics, including biosimilars, enhances patient safety. Where there are multiple companies developing a biosimilar of the same reference molecule, distinct non-proprietary names for each of those biosimilars is fundamental to traceability.

Physicians need complete and accurate data on adverse events linked to a specific treatment to facilitate optimal prescribing for each of their specific patients every time. An infrastructure that supports the ability to track and trace the use of different biologics, including biosimilars, across the entire life cycle — from manufacturing to patient intake to post-treatment follow-up — is required to enable optimal patient safety monitoring.

Pharmacovigilance All biologic medicines, including biosimilars, present at least some risk of an unwanted immune response to the medicine, where the patient reacts against the proteins in the medicine.1 The timely reporting of this and other adverse events is important. Just as important is ensuring that the adverse event is attributed to the correct biologic manufacturer. To manage the risk of adverse events and protect patients, it is important to have pharmacovigilance programs for each biologic, including each biosimilar medicine. Pharmacovigilance programs include procedures that monitor the safety of medicines to detect, assess, understand and prevent future adverse effects or other safety-related issues.

Naming and Traceability An important tool to track and trace the use of a medicine given to a patient is a distinguishable International Non-proprietary Name (INN) for each medicine, including biosimilars. INNs were developed to facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property.2 If the INN for a biosimilar is the same as that of the reference biologic medicine, a pharmacist may unknowingly and inappropriately substitute one biosimilar for another biosimilar or the reference biologic medicine.3 In such a case, when prescribing a biosimilar medicine, the treating physician may not know precisely which medicine a pharmacist gave to treat the patient and this is critical for understanding any adverse events. The current INN-based tracking and tracing systems for all medicines are mainly suited for pharmaceutical tracking within the payment systems, not necessarily for tracking and tracing of adverse events.4 Biosimilars are complex large molecules and cannot be substituted like generics because biosimilar product quality and integrity (the critical quality attributes) will differ for each manufacturer.5

Amgen, a developer of both originator products and biosimilars, believes prompt identification of medicinal product problems can be enabled by distinguishable non-proprietary names, which will ultimately enhance patient safety.